Anna Wolf1, Jörg Fuchs1,2, Harald G Schweim1. 1. 1 Department of Drug Regulatory Affairs at the Institute of Pharmacy, University of Bonn, Bonn, Germany. 2. 2 PAINT-Consult®, Jena, Germany.
Abstract
BACKGROUND: Package leaflets of medicines distributed within the European Union should use the template headings and standard texts created by the Working Group on the Quality Review of Documents (QRD). The following study investigated how the QRD template is implemented in this patient information. METHODS: All English-language package leaflets available on the European Medicines Agency website for centralized authorization procedures were downloaded 3 times, separated by a time period of 1 year. A catalog of criteria was applied to analyze QRD template text use. RESULTS: Because of the rapid implementation of updates, the template text used in each package leaflet (N = 565) increased from an average of 444 words in the first download to 565 words during the 2 subsequent years. With template version 7, the fraction of template text per leaflet was 19.7% in 2011, which increased to 21.5% in 2013 with implementation of version 9. CONCLUSIONS: Limitation to mandatory contents through stricter use of the QRD template's bracketing convention, which would reduce package leaflets' text without loss of essential information, is suggested. In addition, making the current QRD template more concise is strongly recommended.
BACKGROUND: Package leaflets of medicines distributed within the European Union should use the template headings and standard texts created by the Working Group on the Quality Review of Documents (QRD). The following study investigated how the QRD template is implemented in this patient information. METHODS: All English-language package leaflets available on the European Medicines Agency website for centralized authorization procedures were downloaded 3 times, separated by a time period of 1 year. A catalog of criteria was applied to analyze QRD template text use. RESULTS: Because of the rapid implementation of updates, the template text used in each package leaflet (N = 565) increased from an average of 444 words in the first download to 565 words during the 2 subsequent years. With template version 7, the fraction of template text per leaflet was 19.7% in 2011, which increased to 21.5% in 2013 with implementation of version 9. CONCLUSIONS: Limitation to mandatory contents through stricter use of the QRD template's bracketing convention, which would reduce package leaflets' text without loss of essential information, is suggested. In addition, making the current QRD template more concise is strongly recommended.